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Specific Protein Analyzer
EUDAMEDClass A (EU MDR)
Ref PA54Model PA50, PA54Ref PA50
Identity
- Trade Name
- Specific Protein Analyzer EUDAMED
- Device Name
- Specific Protein Analyzer EUDAMED
- Model / Reference
- PA50, PA54 EUDAMEDPA54 EUDAMEDPA50 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950334800019 EUDAMED06950334803300 EUDAMED
- Basic UDI-DI
- 69503348PAA001F7 EUDAMED
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
Specific Protein Analyzer by Genrui Biotech Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69503348PAA001F7 | Class A | Active |
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Manufacturer
- Manufacturer
- Genrui Biotech Inc.
- EUDAMED SRN
- CN-MF-000017351
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 3e333a10-b0e6-44bd-bc16-5db20eb330a5 61 fields · synced Jul 21, 2026
- EUDAMED 3ef702a5-fbe4-481b-8d91-3fc840338213 61 fields · synced May 19, 2026